1. Field of the Invention
This invention relates in general to nutraceuticals, including functional foods, dietary supplements, nutritional supplements, medical foods, botanical drugs, and drugs. In particular, it relates to nutraceuticals and methods that are useful for supporting and promoting a healthy calcium and muscle physiology.
2. Statement of the Problem
Currently it is estimated that 10 million individuals have osteoporosis and another 34 million suffer from low bone density. If the effectiveness of prevention efforts does not improve, it is estimated that the public health cost of osteoporosis, including hospitalizations due to broken bones, will rise to $200 billion per year by 2040. The majority of current treatments are pharmaceutically based, such as Fosamax® and the statin category of drugs, or involves simple calcium or calcium/magnesium (Cal/Mag) supplementation. In spite of aggressive therapy, many patients do not respond or improve. Most therapies, even if effective, are limited by side effects. These therapies may be associated with enhanced urinary calcium loss and increased calcium-based urinary stone formation. Finally, even if a drug protocol is effective and without adverse effects for some sub-set of patients, this means that a synthetic drug must be taken every week for drugs such as Fosamax®, or every day for other drugs, for the rest of a patient's life—which could be three or four decades.
Muscle wasting also is on the rise in our society. It long has been associated with increasing age, though now it is recognized as a problem that begins much earlier. The therapy for this, up to now, has been limited to increasing food intake, focusing on protein, minerals and vitamins; that is essentially maintaining a healthy diet in older people.
To date, the etiology of dysfunctional calcium metabolism, muscle wasting, and similar related states is unknown. The optimal approach to such conditions is also unknown. A more physiologically based approach would provide the opportunity for a better chance of achieving and maintaining normal calcium and muscle homeostasis, and preventing and/or treating states of abnormal calcium and muscle physiology.